---
title: "4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethor... — FDA record D-0524-2022 | Is It on Recall"
description: "CGMP Deviations"
url: https://isitonrecall.com/recall/fda-drug-d-0524-2022-4-component-cold-tabs-acetaminophen-325-mg-guaifenesin-200-mg-dextromethorphan-hbr-15mg-phenylephrin/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bu... — FDA record D-0524-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 26, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
- **Reason**: CGMP Deviations
- **Classification**: Class II
- **Recalling firm**: ULTRAtab Laboratories, Inc.
- **Quantity**: 19,103,287 tablets
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0524-2022

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0524-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Product Code: C107L Bulk Lots: 18G085, 19B061, 19F066, 19J068 Product Code: C107LB Bulk Lots: 18J051, 18M079, 18M080, 19B017, 19B018, 19C001, 19C081, 19D056, 19D057 Product C107LA: Bulk lots: 19F067 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Bulk product was distributed to 3 distributors who may have distributed finished product.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Feb 16, 2022
- **Recall initiation date**: Jan 26, 2022
- **Center classification date**: Feb 9, 2022
- **Termination date**: Jan 7, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0524-2022%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Acetaminophen records](https://isitonrecall.com/drug/acetaminophen/) [Medications records](https://isitonrecall.com/category/medications/) [ULTRAtab Laboratories, Inc. records](https://isitonrecall.com/brand/ultratab-laboratories-inc/)